FDA, Intellectual Property, and Related Policy Issues
March 2009
The National Health Council and the FDA Issue Team have worked on several issues impacting the Food and Drug Administration (FDA), such as agency funding, intellectual property, and implementation of PDUFA.
It is expected that the issue of intellectual property law will be revived in the 111th Congress and the Obama Administration. The NHC has received a draft literature review on this issue from our consultants, the law firm of Akin Gump, which will also assist in drafting legislative language for this Congress. The Council would like to use intellectual property laws to direct research into areas that have seen little progress, such as neurologic and autoimmune diseases.
The NHC is also working with our members on the creation of a pathway at FDA for biosimilars. Akin Gump presented a set of domains of interest for this issue, and the FDA Issue Team is working to translate those into a set of values. These values will inform our legislative agenda as bills are introduced. This issue is expected to play a role in health care reform.
The Council also produced comments (enclosed) for the Obama transition team. The comments were delivered by Council President Myrl Weinberg during a meeting with the transition team, at which other ideas for health care reform were also discussed.
The FDA Issue Team will continue to work on these issues, as well as the creation of the Reagan-Udall Foundation, during the 111th Congress. The co-chairs of the FDA Issue Team for 2009 are Steve Gibson of The ALS Association and David Chatel of the National Multiple Sclerosis Society.
Staff contact: Kevin Cain, Assistant Vice President, Government Affairs and Programs
